Support for Human Specimen Banking in NCI-Supported Cancer Clinical Trials

在 NCI 支持的癌症临床试验中支持人体样本库

• 批准号: 7602986
• 负责人: GREGORY H REAMAN
• 金额: $ 119.56万
• 依托单位: NATIONAL CHILDHOOD CANCER FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-03 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7602986
• 关键词: Bioinformatics; Biological; Cancer Patient; Childhood; Children' s Oncology Group; Clinical; Clinical Research Associate; Clinical Treatment; Clinical Trials; Collection; Data; Emerging Technologies; Enrollment; Ensure; Equipment and supply inventories; Evolution; Funding; Goals; Grant; Human; Lead; Link; Malignant Childhood Neoplasm; Malignant Neoplasms; Microscopy; Molecular; Molecular Analysis; Molecular Profiling; Nephroblastoma; Neuroblastoma; Patients; Phase; Population; Procedures; Publications; Quality Control; Research Personnel; Resources; Risk; Specimen; Stratification; Tissue Banking; Tissue Banks; Tissue Microarray; Tissues; Translational Research; Treatment outcome; Work; anticancer research; base; improved; new technology; patient population; population based; quality assurance; sarcoma; soft tissue; treatment trial; virtual

DESCRIPTION (provided by applicant): The Tissue Banks of the Children's Oncology Group have an opportunity to significantly advance pediatric cancer research, in part via the resources provided by this U24 application, in the next 5-year grant cycle. Historically, the banking track record of the COG has been outstanding, producing nearly 300 publications based on biologic specimens since the group was created in March 2003. The goal of the COG in this RFA is to approach biologic cancer specimen procurement as an effort that is nearpopulation-based, similar to the enrollment seen with pediatric clinical cancer trials. This goal will become more achievable as more COG therapy becomes risk-based with inclusion of molecular parameters, as we currently see with ALL, neuroblastoma and Wilms tumor (where specimen procurement rates approach 80 to 90 percent of the clinical population). Soft tissue sarcomas are currently evolving toward such molecular-based risk-stratification for treatment purposes. It is anticipated that such an evolution toward molecular/risk-based therapy will lead to at least a 50 percent procurement rate of specimens for all pediatric cancer patients in the next grant cycle. This should produce some 160,000 specimens obtained from more than 18,000 patients. This procurement will be facilitated by sophisticated procurement kits, detailed bioinformatics for specimen inventory and tracking, group-wide educational seminars (particularly for clinical research associates), and new technologies (virtual microscopy, tissue microarrays). Molecular analysis of tissues will significantly improve quality assurance efforts directed toward improving specimen procurement, storage and delivery. Our Specific Aims are as follows: 1. Establish collection, storage and quality control procedures for tissue banking in pediatric cancer patients that are near-population-based. 2. Ensure proper storage and quality control procedures for pediatric tissue bank specimens that promote outstanding retrospective translational research. 3. Ensure proper administration of tissue bank resources to facilitate investigator access to specimens. 4. Promote linkage of tissue bank resources to existing demographic, clinical, biological, treatment and outcome data. 5. Optimize utilization of finite tissue bank resources utilizing emerging technologies.

描述（由申请人提供）： 儿童肿瘤组的组织库有机会在下一个5年资助周期内，通过U24申请提供的资源，显著推进儿科癌症研究。从历史上看，COG的银行业记录一直很出色，自2003年3月成立以来，该组织根据生物标本制作了近300份出版物。在本RFA中，COG的目标是将生物癌症标本的获取作为一种接近基于人群的努力，类似于儿科临床癌症试验的招募。随着越来越多的COG治疗变得基于风险并纳入分子参数，这一目标将变得更容易实现，正如我们目前在ALL，神经母细胞瘤和Wilms肿瘤中所看到的那样（其中标本采集率接近临床人群的80%至90%）。软组织肉瘤目前正朝着这种基于分子的风险分层的治疗目的。 预计这种向分子/基于风险的治疗的演变将导致下一个资助周期中所有儿科癌症患者的标本采购率至少达到50%。这将产生从18 000多名病人身上获得的约160 000份标本。这一采购将通过先进的采购工具包、用于标本库存和跟踪的详细生物信息学、全集团范围的教育研讨会（特别是针对临床研究助理）和新技术（虚拟显微镜、组织微阵列）来促进。组织的分子分析将显著改善质量保证工作，旨在改善标本的采购、储存和交付。 我们的具体目标如下： 1.建立儿科癌症患者组织库的收集、储存和质量控制程序，以接近人群。 2.确保儿科组织库标本的适当储存和质量控制程序，以促进杰出的回顾性转化研究。 3.确保组织库资源的适当管理，以便于研究者访问标本。 4.促进组织库资源与现有人口统计学、临床、生物学、治疗和结果数据的联系。 5.利用新兴技术优化有限组织库资源的利用。